The effect of synbiotic supplementation on hypothyroidism: A randomized double-blind placebo controlled clinical trial.

OBJECTIVE: We hypothesize that synbiotic supplementation could modulate the intestinal microbiota and subsequently, improve the condition of hypothyroid patients. METHODS: Fifty-six adult hypothyroid patients were recruited to this double-blind, placebo-controlled, randomized clinical trial. The intervention was 10 weeks of synbiotic (500 mg of 109 CFU/g probiotics plus fructo-oligosaccharide, n = 28) compared to placebo (lactose, magnesium stearate, talc, and silicon dioxide, n = 28). Randomization and allocation to trial groups were carried out using random number sequences drawn from https://sealedenvelope.com/. Primary outcomes were serum thyroid stimulating hormone (TSH) and free thyroxine (FT4), and secondary outcomes were depression, quality of life, and blood pressure (BP). P-values< 0.05 were considered statistically significant. RESULTS: Analysis on 51 patients who completed the trial showed that TSH and depression (p> 0.05) did not change significantly, while serum FT4 significantly increased in both groups (p = 0.03 and p = 0.02 in symbiotic and placebo respectively). A significant decrease in systolic BP occurred only in the synbiotic group (p = 0.05). Significant improvements occurred regarding different domains and areas of quality of life in the crude and adjusted analysis, including perceived mental health (p = 0.02), bodily pain (p = 0.02), general health perception (p = 0.002), and wellbeing (p = 0.002), which were significantly higher in the synbiotic group. CONCLUSIONS: Ten-week supplementation with synbiotic had no favorable effect on depression and TSH, but it improved blood pressure and quality of life in patients with hypothyroidism. More trials are needed to support or reject these findings. TRIAL REGISTRATION: IRCT20210926052583N1, Iranian Registry of Clinical Trials (IRCT), registered October 1st, 2021.

Effect of supplemental vitamin D3 on bone mineral density: a systematic review and meta-analysis.

CONTEXT: There is still controversy over the effect of vitamin D3 supplementation on bone health. OBJECTIVE: The effects of vitamin D3 supplementation on bone mineral density (BMD) and markers of bone turnover, as well as the dose-response relationship between vitamin D3 and bone health in adults, were evaluated. DATA SOURCES: The PubMed, Scopus, Cochrane, Web of Science, and AGRIS databases were searched for articles published through April 30, 2022. Thirty-nine of the 6409 records identified met the inclusion criteria. DATA EXTRACTION: Data were extracted from articles by 2 authors, and data extraction was cross-checked independently. A random-effects model was used to estimate the pooled effect size and the associated 95%CI for the effect of vitamin D3 for each outcome. A one-stage random-effects dose-response model was used to estimate the dose-response relationship between vitamin D3 supplementation and BMD. DATA ANALYSIS: Results of meta-analysis showed a beneficial effect of vitamin D3 at the lumbar spine (standardized mean difference [SMD] = 0.06; 95%CI, 0.01-0.12) and femoral neck (SMD = 0.25; 95%CI, 0.09-0.41). Dose-response analysis revealed a linear relationship between vitamin D3 supplementation doses and BMD at the femoral neck, lumbar spine, and total hip sites. No significant effect of vitamin D3 supplementation on whole-body or total hip BMD was observed (P > 0.05). Vitamin D3 supplementation significantly decreased BMD at both proximal and distal forearm (SMD = -0.16; 95%CI, -0.26 to -0.06). The variables of ethnicity, age, baseline 25-hydroxyvitamin D (25[OH]D), menopause status, vitamin D3 dosing frequency, and bone health status (P interaction = 0.02) altered the effect of vitamin D3 supplementation on BMD. Additionally, a nonlinear relationship between vitamin D3 supplement doses and markers of bone turnover was found. CONCLUSION: A protective effect of vitamin D3 supplementation on BMD of the lumbar spine, femoral neck, and total hip is implicated. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration number CRD42017054132.

The effect of synbiotic supplementation on thyroid hormones, blood pressure, depression and quality of life in hypothyroid patients: A study protocol for a randomized double-blind placebo controlled clinical trial.

BACKGROUND: The prevalence of hypothyroidism is increasing worldwide. Emerging evidence suggests that modulating the gut microbiota in patients with hypothyroidism through prebiotic and probiotic supplementation may have beneficial health effects. We hypothesize that selective modulation of the intestinal microbiota by synbiotic supplementation could improve metabolic status, mood, and quality of life in hypothyroid patients. METHODS: Fifty-six patients with immune and non-immune-related hypothyroidism will be recruited to this double-blind, placebo-controlled, randomized clinical trial with a parallel design. Eligible patients will be selected according to the inclusion criteria through a random sampling method, and will be randomly allocated to 10 weeks of synbiotic therapy or placebo. The primary outcome will be serum thyroid hormones including FT4 and TSH. Secondary outcomes will be systolic & diastolic blood pressure, depression, and quality of life. The data will be compared within and between groups using statistical methods via STATA software (version 14). This study will be conducted at Baqiyatallah hospital, Tehran, Iran. DISCUSSION: Preliminary studies indicate that synbiotic therapy may be a promising, tolerable, and cost-efficient therapy for lowering serum concentrations of thyroid hormones and complications of hypothyroidism. We hope the results of the present trial, positive or negative, will provide high quality proof-of-concept data to elucidate the possible efficacy of this innocuous nutritional therapy in hypothyroidism, and the results could be translated into clinical benefit. TRIAL REGISTRATION: The research is a registered clinical trial (Registration number: IRCT20210926052583N1, Iranian Registry of Clinical Trials (IRCT), registered October 11, 2019.

The association between dietary patterns and quality and duration of sleep in children and adolescents: A systematic review.

BACKGROUND: Dietary pattern has been represented as a contributor to the duration and quality of sleep. This study aimed to review the evidence on this relation among children and adolescents. STUDY DESIGN: This was a systematic review on the association of dietary pattern and sleep. METHODS: A literature search was conducted for all articles published between 1980 and August 2020 using the terms "diet" AND "sleep" in PubMed/Medline, Scopus, Web of Science, Cochrane, and Embase databases. Screening and selection of eligible studies were performed by two separate investigators. Studies reporting the impact of different dietary patterns and indices on sleep duration or quality were included. RESULTS: Fourteen publications (12 cross-sectional, 1 cohort, and 1 clinical trial) were identified. Findings from most studies suggested that long sleep duration was consistently associated with healthy dietary patterns, such as "Vegetables & Healthy Proteins", "Traditional", "Fruit & Vegetables", etc. Results were more mixed and inconclusive regarding the quality of sleep, with 2 studies supporting, 2 studies disapproving, and one study neutral about the association between better sleep quality and healthier dietary patterns. The association between diet and sleep seemed to be affected by confounders and covariates, including sex, physical activity, screen time, etc. CONCLUSIONS: Longer sleep duration appears to be associated with healthier dietary pattern. However, various results in regard to the relation between dietary patterns and sleep quality preclude definitive conclusions. Further research with standard measures of sleep quality and experimental study designs are needed to better define the causal relationship between sleep and diet.

Effect of spirulina and chlorella alone and combined on the healing process of diabetic wounds: an experimental model of diabetic rats.

BACKGROUND: Using chemical agents to cure diabetes mellitus and its complications may be accompanied by complications. New natural agents, such as spirulina and chlorella, could be used as alternative choices in this case. METHODS: 65 male Wistar rats were allocated to 5 groups: A (healthy control), B (diabetic rats with a normal diet), C (diabetic rats supplemented with 50 g/kg/day spirulina), D (diabetic rats supplemented with 50 g/kg/day chlorella) and E (diabetic rats supplemented with 25 g/kg/day chlorella and 25 g/kg/day spirulina). After 21 days, wounds were inflicted on the back of rats. Assessment of blood sugar (BS), high-sensitivity C-reactive protein (hs-CRP), vascular endothelial growth factor (VEGF), granulation tissue formation, vascularization, epithelialization, and percentage of wound healing were determined along with macroscopic examinations. RESULTS: The microscopic changes at days 3, 7, 14, and 21 showed significant evidence of improved angiogenesis, epithelial proliferation, and granulation tissue formation in the spirulina and chlorella treated rats compared with the controls (p˂0.05). Both spirulina and chlorella treatments of diabetic rats resulted in a significant reduction in BS and weight (p˂0.05), but VEGF and hs-CRP levels did not significantly change (p > 0.05). Percentage of wound healing was 100% on day 21 in all groups, except the control group B (97.8 ± 1.15%). CONCLUSIONS: The results of this study showed that supplementation with spirulina and chlorella alone and combined could improve wound healing indices in diabetic rats and could therefore be recommended for the management of diabetic ulcer.

Dietary glycemic index, glycemic load, insulin index, insulin load and risk of diabetes-related cancers: A systematic review of cohort studies.

BACKGROUND & AIMS: It is believed that diets high in glycemic index (GI), glycemic load (GL), Insulin index (II), and Insulin load (IL) are associated with the increased risks of certain cancers through increasing serum glucose or insulin levels. METHODS: We conducted this systematic review of cohort studies to evaluate the possible relation between GI, GL, II, and IL with diabetes-related cancers, including colorectal, bladder, breast, endometrium, liver, pancreas, and prostate cancers. Two separate investigators conducted a literature search through PubMed/Medline, Scopus, and Web of Science databases up to February 2020, plus reference lists of relevant articles. RESULTS: Fifty-three cohort studies with a total of 100 098 cancer cases were included in this systematic review. Fifteen out of eighteen studies among breast cancer cases reported no significant association between GI/GL and cancer risk. These numbers were 4 out of 13 for colorectal cancer, 7 out of 9 for endometrial cancer, 2 out of 3 for liver cancer, 8 out of 10 for pancreatic cancer, and 3 out of 3 for prostate cancer. Only one cohort investigated this association in terms of bladder cancer and reported a significant association. Also, five studies reported this relation in terms of II/IL, and only one cohort among endometrial cancer patients observed a significant positive association between the risk of cancer and IL. CONCLUSION: We concluded a weak association between dietary GI/GL and no association between II/IL with diabetes-related cancer risk. More cohort studies are required to be performed regarding II/IL and the risk of cancer.

Can vitamin E supplementation affect obesity indices? A systematic review and meta-analysis of twenty-four randomized controlled trials.

BACKGROUND: Several mechanisms have been proposed for the effect of vitamin E on weight loss. Yet various interventional studies with wide ranges of doses and durations have reported contradictory results. METHODS: Cochrane Library, PubMed, Scopus, and Embase databases were searched up to December 2020. Meta-analysis was performed using random-effect method. Effect size was presented as weighted mean difference (WMD) and 95% confidence interval (CI). Heterogeneity was evaluated using the I2 index. In order to identification of potential sources of heterogeneity, predefined subgroup and meta regression analyses was conducted. RESULTS: A total of 24 studies with 33 data sets were included. There was no significant effect of vitamin E on weight (WMD: 0.15, 95% CI: -1.35 to 1.65, P = 0.847), body mass index (BMI) (WMD = 0.04, 95% CI: -0.29 to 0.37, P = 0.815), and waist circumference (WC) (WMD = -0.19 kg, 95% CI: -2.06 to 1.68, P = 0.842), respectively. However, subgroup analysis revealed that vitamin E supplementation in studies conducted on participants with normal BMI (18.5-24.9) had increasing impact on BMI (P = 0.047). CONCLUSION: There was no significant effect of vitamin E supplementation on weight, BMI and WC. However, vitamin E supplementation might be associated with increasing BMI in people with normal BMI (18.5-24.9).

Effect of quercetin on oxidative stress and liver function in beta-thalassemia major patients receiving desferrioxamine: A double-blind randomized clinical trial.

BACKGROUND: Blood transfusion therapy is lifesaving for beta-thalassemia major patients, yet it indirectly causes complications such as oxidative stress and liver dysfunction. In the present study, we investigated the effect of quercetin supplementation on oxidative stress and liver function in beta-thalassemia major patients. MATERIALS AND METHODS: In this double-blind clinical trial, 84 beta-thalassemia patients who received desferrioxamine (DFO) were randomly assigned to two groups; the treatment group received 500 mg quercetin tablet daily for 12 weeks, and the control group received placebo. In addition to demographic and anthropometric assessment, malondialdehyde (MDA), total antioxidant capacity (TAC), superoxide dismutase (SOD), glutathione peroxidase (GPx), aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) were biochemically assessed to detect the effect of quercetin on oxidative stress and liver function, respectively. The data were analyzed using SPSS 21. P < 0.05 was considered statistically significant. RESULTS: Before adjusting for confounding variables, within-group comparison showed that quercetin supplementation reduced ALT (P < 0.001) and TAC (P < 0.001) significantly. Between-group comparison using analysis of covariance analysis though showed that quercetin could significantly reduce ALT (P = 0.002), but there was an insignificant increase in SOD and TAC, and insignificant decrease in GPx, MDA, AST, and ALP (P > 0.05). CONCLUSION: According to our results, consumption of 500 mg quercetin supplement daily for 3 months along with DFO treatment might be able to alter liver function, but not the oxidative stress in beta-thalassemia major patients.

The effect of quercetin on iron overload and inflammation in ß-thalassemia major patients: A double-blind randomized clinical trial.

OBJECTIVES: The aim of this study was to determine whether quercetin can reduce iron overload and inflammation in thalassemic patients. METHODS: Eighty four patients were recruited to this study and randomly assigned to two groups: 42 patients received a 500 mg/day quercetin tablet and 42 others took a 500 mg/day starch placebo for 12 weeks. Demographic, anthropometric and biochemical evaluation were performed. RESULTS: ANCOVA analysis revealed that compared to the control group, quercetin could reduce high sensitivity C-reactive protein (hs-CRP) (P = 0.046), iron (p = 0.036), ferritin (p = 0.043), and transferrin saturation (TS) (p = 0.008) and increase transferrin (p = 0.045) significantly, but it had no significant effect on total iron binding capacity (TIBC) (p = 0.734) and tumor necrosis factor α (TNF-α) (p = 0.310). CONCLUSIONS: Quercetin could ameliorate the iron status in thalassemia major, but its effect on inflammation is indistinctive.

Effect of egg consumption on inflammatory markers: a systematic review and meta-analysis of randomized controlled clinical trials.

There is little evidence about whether eggs affect inflammation. The aim of this meta-analysis was to explore the effects of egg consumption on inflammation. A systematic search of online databases (Institute for Scientific Information (ISI), Scopus, Ovid, PubMed, Cochrane) was used to gather clinical trials that assessed the effect of egg consumption on circulating inflammatory biomarkers. Using a random-effects model, pooled weighted mean differences (WMD) and corresponding standard deviations (SD) were calculated. Of the 21 eligible studies found, nine trials were eligible for analysis. Eight trials assessed high-sensitivity C-reactive protein (hs-CRP), four trials assessed interleukin-6 (IL-6), and five trials assessed tumor necrosis factor-alpha (TNF-α). Egg consumption did not affect hs-CRP (WMD 0.24 mg/L; 95% CI: -0.43, 0.90; I2  = 53.8; P = 0.48), IL-6 (WMD 0.20 pg/mL; 95% CI: -0.71, 1.11; I2 = 69.3; P = 0.50), and TNF-α (WMD: -0.38 pg/mL; 95% CI: -0.87, 0.10; I2 = 0.00; P = 0.12) relative to controls. Overall, this meta-analysis revealed that egg consumption had no significant effect on serum biomarkers of inflammation in adults. © 2019 Society of Chemical Industry.